Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Confirmation of BIBF 1120 administered from 150 mg twice daily (b.i.d.) to 250 mg b.i.d. as safe and tolerable treatment in Japanese patients with advanced solid tumours, overall safety, pharmacokinetic parameters, biomarkers, and efficacy of BIBF 1120.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBF 1120 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBF 1120 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose Limiting Toxicities (DLT) associated with increasing doses of BIBF 1120 | Up to 36 months | |
| Incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTCAE Version 3.0) associated with increasing doses of BIBF 1120 | up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| maximum tolerated dose (MTD) of BIBF 1120 | Up to 36 months | |
| Objective tumour response according to the response evaluation criteria in solid tumours (RECIST) | Up to 36 months | |
Not provided
Inclusion Criteria:
Male or female patients with a confirmed diagnosis of an advanced, non resectable and/or metastatic solid tumour (except for malignant lymphoma)
Patients who have not responded to conventional treatment, or for whom no therapy of proven efficacy was available, or who were not amenable to established forms of treatment
Patients recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radio-therapies (except for epilation) at least over the following periods of time:
Age 20 years or older
Life expectancy of at least 3 months
Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2
Patients retaining a significant physiological compensatory function and without manifest marked disorders of the hematopoietic system, heart, lung, liver, kidneys, etc., i.e., patients with sufficient baseline organ function
No participation in other clinical trials within 4 weeks before start of therapy within this trial
Written informed consent given that is consistent with ICH-GCP guidelines
Exclusion criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C530716 | nintedanib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 12 hours after single dose administration (AUC0-12) |
| before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the first drug administration |
| Change from baseline in peripheral blood biomarkers | Baseline, day 2, day 8, day 30 |
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24hours after single dose administration (AUC0-24) | before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration |
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable analyte plasma concentration after single dose administration (AUC0-tz) | before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration |
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single dose administration (AUC0-∞) | before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration |
| The percentage of the AUCtz-∞ that is obtained by extrapolation (%AUCtz-∞) | before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration |
| Maximum measured concentration of the analyte in plasma following a single dose (Cmax) | before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration |
| Time from dosing to the maximum concentration of the analyte in plasma following a single dose (tmax) | before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration |
| Terminal half-life of the analyte in plasma after single dose administration (t1/2) | before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration |
| Terminal rate constant in plasma after single dose administration (λz) | before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration |
| Mean residence time of the analyte in the body after single dose oral administration (MRTpo) | before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration |
| Apparent clearance of the analyte in plasma after single dose extravascular administration (CL/F) | before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration |
| Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F) | before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration |
| Area under the concentration-time curve of the analyte in plasma at steady state over the time interval from 0 to 24hours (AUC0-24,ss) | before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration |
| Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss) | before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration |
| Τime from last dosing to the maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (tmax,ss) | before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration |
| Terminal half-life of the analyte in plasma at steady state (t1/2,ss) | before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration |
| Terminal rate constant in plasma at steady state (λz,ss) | Up to 36 month |
| Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss) | before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration |
| Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss) | before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration |
| Average concentration of the analyte in plasma at steady state (Cavg) | before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration |
| Mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss) | before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration |
| Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration (CL/F,ss) | before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration |
| Apparent volume of distribution during the terminal phase λz at steady state following extravascular administration (Vz/F,ss) | before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration |
| Accumulation ratio (RA) | Up to 36 month |
| Predose concentration of the analyte in plasma immediately before administration of the n-th dose (Cpre,n) | Day 8, 15 and day 22 after start of treatment |